Cephalon, Inc.

FRIDAY, Sept. 20, 2024 -- Controversial fentanyl lollipops and similar products will no longer be made by drug makers, the U.S. Food and Drug Administration has announced. Known as TIRF medications, these products contain fentanyl and are used to manage breakthrough pain in cancer patients who have become tolerant to around-the-clock opioid therapy, the FDA said in a statement released this week. The decision by drug makers to stop selling such medicines follows decades of investigations and lawsuits against the drugmakers that had marketed the fast-acting painkillers too aggressively, CBS News reported. In 2020, the FDA first tightened prescribing restrictions on the products, in response to data suggesting they were being given to patients who are not opioid-tolerant. Drugmaker Cephalon had the FDA's approval to market these drugs for years under brand names like Actiq , a sweetened lozenge on a stick, or Fentora , a tablet that dissolves in the mouth. Generic pharmaceutical manufacturer Teva Pharmaceuticals acquired Cephalon in 2011, when the market for Actiq was worth around $173 million a year, CBS News reported. Teva officials did not respond Thursday to a request for comment on why it will stop selling the products, CBS News reported. In 2022, Teva settled lawsuits from state and local governments that had accused the company of promoting Actiq and other powerful fentanyl painkillers for patients without cancer and downplaying addiction risks. Teva will stop selling the products on Sept. 30, the FDA said. "FDA did not request this discontinuation. It is important to note that FDA does not manufacture medicine and cannot require a pharmaceutical company to make a medicine, make more of a medicine or change the distribution of a medicine," the agency added. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Peter R. Dolan, former Chairman and CEO of Bristol Myers Squibb Joins the Board of Aveta Biomics Bedford, MA – August 1, 2024 – Aveta Biomics, a pioneering oncology company developing first-in-class, oral immuno-oncology drugs, is pleased to announce that Mr. Peter R. Dolan has joined its Board of Directors. Mr. Dolan has an impressive track record of leadership in the pharmaceutical industry as the former CEO and Chairman of Bristol-Myers Squibb (BMS). His 18 transformative years guiding BMS through significant strategic initiatives brought blockbuster drug Eliquis to its portfolio, and investment in ImClone’s Erbitux, a key treatment for solid tumors, including Head & Neck Cancer. He also licensed the immuno-oncology drug Yervoy, pivotal to BMS’s oncology business, and oversaw substantial investments in biologics. “Joining the board of Aveta Biomics is an exciting opportunity,” said Peter Dolan. “Aveta’s unique approach to cancer treatment, and impressive Phase 2 results can be a potential game-changer. Aveta’s drugs could be both inherently safe and highly effective, without the typical trade-offs seen in cancer treatment. I look forward to collaborating with the board and management to push forward to bring a new class of oncology treatments to the patients.” Mr. Dolan currently chairs the Board of Trustees at Tufts University and the Partnership for A Healthier America. Post-BMS, he successfully led GeminX, an oncology company, to a $225 million acquisition by Cephalon Pharmaceuticals. More recently he served on the Board of Directors of Amplitude Health Care, a Special Purpose Acquisition Company which merged with with Jasper Therapeutics. “We’re beyond excited to have Peter Dolan join our board,” said Dr. Parag G. Mehta, CEO of Aveta Biomics. “Peter has a formidable track record of successes in getting groundbreaking therapies to patients. His strategic insights will help steer Aveta Biomics towards new horizons in cancer treatment and make our big dreams a reality.” Mr. Dolan’s distinguished career includes board roles at American Express, ChildObesity180 (as Chairman), and Dartmouth’s Tuck School Board of Overseers. He holds a BA magna cum laude from Tufts University and an MBA from the Tuck School of Business at Dartmouth College. About Aveta Biomics: Aveta Biomics is an oncology company committed to developing next-generation of safer and highly effective cancer drugs based on mimicking the functions of body’s endogenous metabolites and processes. Aveta’s drugs stimulate the immune system to destroy cancer cells while sparing healthy cells. Aveta is conducting multiple clinical trials for head and neck cancer and glioblastoma. Contact Information: Ms. Hema Gandhi, Media Representative Aveta Biomics betterhealth@avetabiomics.com www.avetabiomics.com

~ Recent advancements signify a new era in liver disease diagnosis and treatment. ~ GREENVILLE, SC May 15, 2024 – Luxor Scientific and CIMA Sciences join forces for the US launch of OWLiver®, an exclusive non-invasive blood test able to detect all dangerous stages of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic dysfunction-Associated Steatohepatitis (MASH). The OWLiver® metabolic assay meets the urgent need for a non-invasive test for identification of individuals who have “at-risk” MASH and are at high risk for progressing to end-stage liver disease. This collaboration coincides with the FDA's March 2024 approval of the first and only medication for MASH treatment, marking a transformative step forward in enhancing liver disease testing and management. Luxor Scientific is the only laboratory offering CIMA Sciences’ OWLiver® testing in the US, which utilizes the MASEF® (Metabolomics-Advanced Steatohepatitis Fibrosis) score.1 With advanced metabolomics technology, this test holds the potential to transform approaches in understanding and treating metabolic dysfunction associated liver conditions. "As we continue to see a rise in metabolic syndrome in the US, MASLD is becoming more and more prominent,” stated Dr. Marion Snyder Luxor Scientific. “For years, physicians have had to rely on invasive liver biopsy procedures and costly imaging studies. OWLiver® can identify MASLD in its early stages, giving patients the chance to stop and reverse the disease and live a healthier lifestyle.” MASLD, previously known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most common cause of chronic liver disease, impacting over 30% of adults in the US, and is expected to increase in the coming years with the steady rise of obesity, diabetes, and metabolic syndrome. As many as 20% of type 2 diabetic individuals with MASLD will develop MASH. Studies show that 15-20% of patients with MASH can progress to liver disease and ultimately liver failure. Early identification of “at-risk” MASH is a priority, as these patients are at increased risk for disease progression and may benefit from developed therapies to prevent the disease and further liver damage and related complications. “The availability of this test is incredibly significant for patients at this time,” expressed Alejo Llopart-Mascaro, CIMA Sciences. "We take pride in our collaboration with Luxor Scientific to address the growing issue of metabolic associated liver disease. This partnership enables healthcare providers to diagnose and subsequently offer effective treatments that are now readily available to their patients." About CIMA Sciences, LLC Strategically bringing proprietary technology to the US, CIMA Sciences is a biological company which primary focus is on developing and providing the scientific community and the US population with cutting-edge, non-invasive diagnostic technologies for high-prevalence diseases, with a specific emphasis on liver and cardiovascular risk. CIMA recognizes the critical need for accurate and early detection of diseases and aims to revolutionize the diagnostic landscape and empower healthcare professionals with groundbreaking, accurate, non-invasive and accessible tools to identify and manage these conditions effectively. CIMA actively collaborates with key stakeholders in the scientific and medical communities to ensure the effective deployment of its solutions and their integration into existing healthcare systems. For more information about CIMA Sciences, please visit About Luxor Scientific Luxor Scientific was founded with the mission of providing better information faster. As a full-service privately-held CAP-accredited medical and research laboratory, Luxor offers a robust menu of clinical and anatomical testing services. Today, Luxor Scientific is one of the fastest-growing companies in the southeast, specializing in cutting-edge diagnostic testing solutions in the areas of metabolomics, genomics, toxicology and histology. Luxor’s industry-leading turnaround times and state-of-the-art equipment and diagnostic solutions, allows Luxor to provide personalized service, accurate testing, and innovative functional reporting. For more information about Luxor Scientific and our full test offering, please visit . [1] The Metabolomics-Advanced steatohepatitis fibrosis score (MASEF). Hepatology. 2024 Jan 1;79(1):135-148.doi: 10.109724 Media Contact: Kristina Loughrey kristina@klcoms.com